Surgical devices used to stabilize bones during orthopedic surgical procedures, such as compression staples, are well known in the art. To correct and heal bone fractures properly, staples are often used to keep bone fragments in position by holding and compressing the bone fragments together without motion. Various staples have been produced to provide compression in various manners.
For example, U.S. Pat. Nos. 6,059,787, 6,348,054, 6,783,531 describe surgical staples and methods that use a spring-type force to create a compression effect. The staples disclosed in these patents require the spreading apart of the staples' legs to create a spring-type force before applying a percussive force to drive the staples into the bone with a resultant compressive effect. Similarly, U.S. Pat. No. 5,785,713 discloses a staple, which has the staple's legs in an initial angled orientation, and the legs must be spread apart to a parallel configuration before inserting the staple into bone. However, fractures may arise from driving the compound-shaped legs into the bone. Also, the mechanism employed for such staples is less than optimal in that the staple's legs converge at their ends to create compression, which provides little to no compression at the bridge end of the staple.
U.S. Patent Application Publication No. 2007/0276388 discloses surgical staples and annulus closure tools, having two to four legs, for sealing inter-vertebral disk incisions or herniations. A disadvantage of all of the aforementioned staples is that the percussive force applied to drive the staples is quite abrasive and a more controllable method of insertion would be a more advantageous surgical technique. Also, there is no guidance prior to insertion for the precise placement of the staples.
U.S. Pat. No. 4,994,063 describes a method and bone staple for interosseous bone compression. Such staples and methods, however, have common insertion techniques that are extremely difficult to complete. A typical technique initially requires drilling holes for a staple using a drill guide. The drill guide is removed before inserting the staple. In many cases the holes are lost due to blood, debris, and soft issue in the surrounding area that fill into the holes. Thus, it is difficult to accurately assess the location of the holes under fluoroscopy using this technique. For these reasons, staples are placed inaccurately and the holes must be re-drilled to properly insert the staple and repair the bone.
As an attempt to overcome this problematic insertion technique in the field, surgical devices that may be cannulated and used with guides have been introduced. However, such attempts are problematic for other reasons. For example, U.S. Patent Application Publication No. 2007/0093839 describes a compression staple for securing tissue. The two legs of the staple may be cannulated and the reference teaches the following method of insertion: a first guide pin is driven into the first tissue; one of the legs of the staple is inserted over the first guide pin; the staple is aligned in the desired position; a second guide pin is driven into the second tissue; the second staple leg is inserted over the second guide pin, and finally; the staple is driven into the tissue. The prior art fails to teach an easy method of insertion that provides for precise placement of both legs of the staple at the same time. Further, predrilled holes are not used for placement of the staple and the staple must be driven into the bone with percussive force. Another disadvantage of cannulated staples is that they have hollow anchoring members and thus provide a weak structure for purposes of holding bone fragments together. The current devices do not disclose a robust staple or an insertion technique that is precise, quick, not destructive to the bone, and easy.
Therefore, what is needed in the art is an improved surgical staple with increased strength and an improved method that allows for easy and precise insertion into bones or tissues compared with the current methodologies known in the art. With these goals in mind, the inventor has created a robust staple with improved structural properties and compression capabilities, as well as an easy and effective insertion technique and system thereof for stabilizing bones with compression staples during orthopedic and podiatric type surgical procedures.
Surgical devices having a bridge portion that is adjustable so the staple's legs can be adjusted to the better fit and fix bones angled in various positions at a known amount of compression are also not disclosed in the prior art. Nor does the prior art disclose staples that can be easily used for distraction, e.g., maintaining an osteotomy open for re-alignment of bones. The prior art describes staples in which the bridge can be expanded lengthwise to change the distance between the legs of the staples. For example, U.S. Patent Application Publication Nos. 2009/0062799 and 2002/0103489 describe staples in which the length of the bridge can be adjusted. U.S. Pat. No. 4,913,144 discloses a staple in which the position of the staple's legs can be moved towards or away from each other by a dovetail joint on the bridge. The dovetail joint allows for movement of the staple's legs only in this manner. The prior art also does not disclose a device that is capable of maintaining compression at a known amount for a set amount of time. Further, the staples known in the prior art do not include detached legs that can be assembled with the bridge of the staple.
Thus, what is needed is a device with a bridge having one or more adjustable anti-reversing portions on the bridge that allow for not only repositioning of the distance and angle between the legs of the staple, but also the angle of the bridge of the staple itself while maintaining compression or distraction of bones. What is also needed is a device with a bridge having one or more adjustable anti-reversing portions so that the device maintains the compression or distraction. With these goals in mind, the inventor has created a device having a bridge with one or more adjustable anti-reversing portions that allow for independent positioning of the legs of the device, based on the angle in which the adjustable anti-reversing portion(s) are positioned. Moreover, the device described herein maintains a known amount of compression after adjustment of the adjustable anti-reversing portion(s). The inventor has also created a device with legs detached from the device's bridge and a device which can be dissembled for easy removal.